Ambulation as a Factor on Oscillating Thermometry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03907189

Acronym

AFOOT

Enrollment

100

Registered

2019-04-08

Start date

2019-03-25

Completion date

2020-12-10

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy Peripheral

Brief summary

This research study aims to better understand how the plantar temperature data collected by the Podimetrics RTM System corresponds to physical activity level in subjects.

Detailed description

Subjects with prescription for monitoring with Podimetrics RTM System will be assigned activity monitors to track physical activity. Data from the Podimetrics RTM System and the activity monitor will be assessed after one month of use to determine any correlation between the two data sets and adherence to the use of activity monitor.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Study subjects must * Be at least 18 years old * Not be pregnant * Provide informed consent * Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System

Exclusion criteria

* Be younger than 18 years old * Unable to understand English * Unable to provide consent * At the discretion of the investigator

Design outcomes

Primary

Measure	Time frame	Description
Correlation of foot temperature data and daily activity in patients with emergent inflammation.	1 month	The primary objective of the study is to examine whether temperature data from subjects with inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with activity as measured by the activity monitor.

Secondary

Measure	Time frame	Description
Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.	1 month	The secondary objective of the study is to examine whether temperature data from patients without inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with subject activity as measure by the activity monitor.

Other

Measure	Time frame	Description
Usage rate for Podimetrics Mat	1 month	The objective is to record the number of distinct days on which subject uses Podimetrics Mat for thermometry reading.
Usage rate for the activity monitor	1 month	The objective is to record the percentage of time the subject uses the activity monitor.

Countries

United States

Outcome results